Job Description:
The Quality Specialist - Quality Systems supports the Quality Systems activities in both Drug Substance and Drug Product facilities at our client site in Tipperary. This is an 11-month initial contract.
Key Responsibilities:
* To provide timely and effective completion of Quality Systems core functions according to schedules, policies, procedures, and guidelines.
* Sub System Ownership: Complete sub system ownership responsibilities as per the site System Ownership list.
* Quality SME for Process, Cleaning, Water, Equipment: Provide leadership and technical assistance regarding validation standards required for a Drug Substance and Drug Product pharmaceutical facility.
* Approval of all validation documentation and ensuring compliance to MMD policies, procedures, and guidelines.
* SAP Quality Process Steward: Quality SME for Change Control; Principle Quality contact for all site change requests with impact on processing.
* Laboratory QA oversight: Support and approve systems supporting laboratory functions, instrumentation, and GLIMS.
* Stability oversight: Review and approval of stability reports.
* Microbiology Point of Contact: Knowledge of microbial requirements in the pharmaceutical industry.
* Quality Agreement System Management: Manage site inventory of Quality Agreements.
* Annual Review System Management: Manage Annual Reviews for products and systems, including automation.
* Quality Oversight of site application User Access Reviews: Approval of all designated user access reviews.
* Quality Council: Manage annual quality council schedule and monthly quality council agenda, minutes, and action follow-up.
* Supplier Change Evaluations - Quality Role: Review and approve Supplier Change Evaluation documentation.
* Supplier and Customer complaints: Participate in investigation and review of internal/external customer complaints.
* Filing & Licence maintenance and Regulatory Requests follow-ups: Review and ongoing maintenance of site licences.
* QA Regulatory Data: Review and verify documentation for regulatory submissions/filings.
* Returned Goods: Manage segregation and disposition of all returned goods.
* Audit program: Support internal GMP walk-down and scheduled audits program.
Requirements:
* Minimum of Degree or post-graduate qualification in Science, Pharmacy, or Engineering field.
* MMD and site quality policies, procedures, and guidelines.
* Relevant GMP standards.
* Global Engineering Standards.
* Plant procedures and policies.
* Plant equipment and Unit Operations.
* Plant layout.
* Plant documentation.
* Laboratory testing and documentation.
* Validation principles and guidelines.